Magnetic Sentinel Lymph Node Mapping in Oral Squamous Cell Carcinoma: A Phase I Feasibility and Validity Clinical Trial

Not Applicable

Completed

• Conditions: Oral Cancer; Cancer - Head and neck

• Registration Number: ACTRN12620000831987
• Lead Sponsor: Central Adelaide Local Health Network trading as Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-21
• Study Completion: 2022-09-30
• Last Update Posted: 13 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Age 18 or older
- Willing to provide informed consent
- ECOG status 0-2
- Biopsy proven T1-T2 oral SCC (tongue, RMT, buccal mucosa, FOM, hard palate)
- Clinically and radiologically N0 neck on contrast enhanced CT or gadolinium enhanced MRI +/- (USS or FDG PET)
- No distant metastases
- Primary tumours amenable to surgical resection

Exclusion Criteria

- Serious medical comorbidities or other contraindications to surgery +/- adjuvant therapy
- Advanced T-stage primary tumour (>T2)
- Primary tumours not amenable to surgical resection
- Previous HNSCC
- Previous head and neck radiotherapy at any time
- Lip involvement
- Allergy or Intolerance to iron oxide or dextran compounds
- Metal implant close to site of sentinel lymph node
- Iron overload disorder
- Standard contraindications to MRI scanning
- Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified